DIA 2026 Global Annual Meeting: Full Schedule

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8:00am EDT

#701: No Report Left Behind: Human-Centered Safety Reporting

Thursday June 18, 2026 8:00am - 9:00am EDT

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-643-L04-P; CME 1.00; RN 1.00

Human-centered safety reporting empowers participants to speak up sooner. This session explores how consent innovation, safety processes, and clinical operations partner to reduce missed reports, protect patients, and strengthen trial integrity.

Learning Objectives

Identify the key factors that contribute to patients underreporting adverse events and assess the resulting impact on safety, operations, and compliance; Describe approaches for applying human-centered strategies—such as engaging people living with the condition and using ongoing comprehension checks—to clarify reporting expectations; Evaluate site-level and technology-enabled practices that support more complete and timely reporting.

Chair

Lani Hashimoto

Speaker

Panelist
Stacy Hurt, MBA, MHA

Panelist
Jennifer Miller, PHD

Speakers

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States

Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →

Jennifer Miller

Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, Yale School of Medicine, United States

Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Feature Topics Patient-Centered Design and Experience
Tags Session

8:00am EDT

#708: Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22

Thursday June 18, 2026 8:00am - 9:00am EDT

102AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-624-L04-P; CME 1.00; RN 1.00

This workshop explores integrating patient preference studies into clinical trial design and drug application submissions, highlighting operational strategies, stakeholder collaboration, and how these align with the upcoming ICH E22 guideline.

Learning Objectives

Recognize key aspects of patient preference studies (PPS) design using a practical, interactive preference elicitation example; Describe how to incorporate PPS into clinical trial design and regulatory decisions using insights from ICH E22; Identify key operational strategies and challenges in designing PPS.

Chair

Bennett Levitan, MD

Speaker

Patient Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Megan Aragon, MBA

Regulatory Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Robyn Bent, BSN, MS, RN

Industry Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Leila Lackey, MHS, PHD

Speakers

Megan Aragon

Technology Services Administrator, East Texas Lighthouse for the Blind, United States

Megan Aragon is the Technology Services Administrator at East Texas Lighthouse for the Blind, where she leads Assistive Technology (AT) strategy and training initiatives. A native AT user, she brings lived experience with vision loss to systems-level program design and service delivery... Read More →

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States

Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). . Ms. Bent also serves as an FDA representative to the Management Committee of the International... Read More →

Leila Lackey

Director, Patient Preference Evidence Generation, Pfizer, United States

Dr. Lackey has a Master of Health Science from Johns Hopkins in Environmental Health Sciences and a doctorate from UCLA in Environmental Science and Engineering. Currently, Dr. Lackey is a Director of Patient Preference Evidence Generation at Pfizer. In this role, she oversees patient... Read More →

Bennett Levitan

Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States

Bennett Levitan, MD-PhD is Executive Director Benefit-Risk (B-R)/Epidemiology at Johnson & Johnson. He introduced state of the art patient-focused B-R to J&J and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
102AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Workshop